(ConservativePeak.com)- “Within days,” Pfizer will seek emergency use authorization from the US Food and Drug Administration for its COVID-19 vaccine, which got some great news on Wednesday.
Earlier in the day, the company said that a final analysis of its Phase 3 trial showed the vaccine was 95% effective in prevention infections. This proved true even in older adults, and there were no serious safety concerns, either.
Out of the people who participated in the trials, 170 got infected with the coronavirus, but 162 of those had received a placebo that didn’t include the vaccine. That means only eight people who received the actual vaccine were infected with coronavirus, leading to the 95% efficacy.
In a joint statement, Pfizer and its partner from Germany, BioNTech, said:
“Efficacy was consistent across age, race and ethnicity demographics. The observed efficacy in adults over 65 years of age was over 94%. There were 10 severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.”
The BNT162b2 label is the expiremental name for Pfizer’s vaccine.
The companies’ statement continued:
“To date, the Data Monitoring Committee for the study has not reported any serious safety concerns related to the vaccine. The only Grade 3 (severe) solicited adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% following dose 2.”
Pfizer said it plans to publish the data from the clinical trials in a peer-reviewed scientific journal and submit it to “other regulatory agencies around the world.”
The CEO and co-founder of BioNTech, Dr. Ugur Sahin, said:
“The rapid protection this vaccine provides — combined with its tolerability profile in all age groups studied so far — should help make this vaccine an important tool to address the current pandemic.”
The Phase 3 clinical trials began on July 27 with 43,661 volunteer participants. Of that total, 41,135 received a second dose of either the vaccine or a placebo. The FDA has said it wants at least two months of safety tracking on the volunteers after they received their second doses.
Pfizer also said they tried to recruit a diverse population of volunteers so it closely matched the groups that were most severely affected during the pandemic. They explained:
“Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age.”
Information regarding safety and efficacy of the Pfizer vaccine will continue to be collected for two more years. There were 150 clinical trial sites based in Brazil, the United States, South Africa, Argentina, Turkey and Germany.
By the end of this year, the companies said the project to produce roughly 50 million doses of their vaccine globally. In 2021, that number will rise to 1.3 billion doses.
Pfizer has three manufacturing sites in the U.S. — in Kalamazoo, Michigan, Andover, Massachusetts, and St. Louis, Missouri.